Important Safety Information About FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

Possible bone cancer. During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.

Who should not take FORTEO?

You should not take FORTEO for more than 2 years over your lifetime.

Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

What should I tell my healthcare provider before taking FORTEO?

Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.

You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO. You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional safety information about FORTEO

There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.org.

The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

How should I store FORTEO?

Keep your FORTEO Delivery Device in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).

About FORTEO

How soon does FORTEO start working?

After you inject FORTEO, you might not notice anything happening. However, in clinical studies, FORTEO increased bone mineral density in the spine at 3 months and continued to increase BMD throughout the treatment period.*†‡ See the descriptions of FORTEO clinical trials below.

*

In a clinical study of FORTEO involving 1,637 postmenopausal women with osteoporosis at high risk for fracture (of whom 90% had a spine fracture), 541 women took a daily 20-mcg dose of FORTEO and
544 took a placebo for a median time of 19 months. All women took calcium and vitamin D daily.

†

FORTEO was examined in an 18-month clinical study of 428 patients who had been treated with a daily dose of 5 mg or more of oral prednisone for a minimum of 3 months.
30% of patients had fractures in the spine and 43% had prior fractures in other locations. In the study, the 214 patients who took FORTEO had taken a median prednisone dose
of 7.5 mg daily, and the median usage time was 1.5 years. All patients took calcium and vitamin D daily.

‡

In a clinical study of FORTEO involving 437 men with primary or hypogonadal (low testosterone) osteoporosis, 151 men took a daily 20-mcg dose of FORTEO and 147 took
a placebo for a median time of 10 months. All men took calcium and vitamin D daily.

I am a male patient. Is FORTEO right for me?

In a clinical study,* FORTEO has been shown to increase bone mineral density in men with primary or hypogonadal (low testosterone) osteoporosis who are at high risk of fracture.
If you are a man, talk to your doctor about whether FORTEO therapy is appropriate for your condition. See the description of FORTEO clinical trial below.

*

In a clinical study of FORTEO involving 437 men with primary or hypogonadal (low testosterone) osteoporosis, 151 men took a daily 20-mcg dose of
FORTEO and 147 took a placebo for a median time of 10 months. All men took calcium and vitamin D daily.

I've never had a bone fracture. Is FORTEO right for me?

FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures). FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures). FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.

If you have osteoporosis, some factors that can put you at higher risk for osteoporotic fracture include:

AgeYour risk of osteoporotic fracture goes up with age.

History of FractureOne fracture may put you at risk for future fractures.

Low BMDThis is measured by your T-score. The lower, or more negative, your T-score (e.g., -2.5 or lower), the more likely you are to fracture due to osteoporosis.

In the end, only your doctor can decide whether you are "high risk" and if FORTEO is right for you.

Is FORTEO a bisphosphonate?

Can I take FORTEO with other medications?

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking FORTEO with other medicines that may harm you. Especially tell your doctor if you take medicines that contain digoxin (such as Digoxin, Lanoxicaps, and Lanoxin).

What are the most common side effects of FORTEO?

The most common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions such as swelling, pain, and bruising. These are not all the possible side effects of FORTEO. For more information, ask your healthcare provider or pharmacist. Click here to see Full Important Safety Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Osteoporotic Fracture

What are some signs that I may have had an osteoporotic fracture?

If you've recently broken a bone, your healthcare professional is the best person to determine if it was due to osteoporosis. However, you may have broken a bone in your back and not realized it. Height loss could be one sign of an osteoporotic fracture in your spine. Your doctor can perform tests to determine if you've had a spine fracture. Remember, one osteoporotic fracture can increase your risk of another fracture.*

Taking FORTEO

How do I take FORTEO?

Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. You can take FORTEO with or without food or drink. See Taking FORTEO for more information.

How often do I need to take FORTEO, and how long does treatment last?

Do I need to inject at the same time every day? What if I forget to take my FORTEO injection?

You should take FORTEO at about the same time each day. If you forget or cannot take FORTEO at your usual time, take it as soon as you can on that day. Do not take more than one injection in the same day.

Once my injection delivery device has been started, how long is it good for?

The FORTEO Delivery Device contains 28 days of medicine. It is set to give a 20-microgram dose of medicine each day. Throw away the FORTEO Delivery Device after 28 days, even if it is not completely empty.

How can I learn to inject myself? Is it difficult?

Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. This site provides a FORTEO Delivery Device User Manual and a FORTEO Delivery Device Demonstration Video, which show you how to use your FORTEO Delivery Device to give yourself injections (or how a caregiver can do them for you). Call 1-866-4-FORTEO (1-866-436-7836) if you need help on how to use your delivery device.

How do I know I injected myself correctly?

The black injection button should be all the way in to show that the full dose of medicine has been injected from the FORTEO Delivery Device. For further assistance, you should consult the User Manual accompanying the delivery device. You can also call 1-866-4-FORTEO (1-866-436-7836) and/or view the FORTEO Delivery Device Demonstration Video. Use a new needle every time you inject to be sure your FORTEO Delivery Device will work properly.

I can't do the injections myself. Am I still able to take FORTEO?

Is the injection painful?

You may experience some pain, swelling, or bruising immediately after your injection, but these effects should go away quickly. If they do not, be sure to contact your healthcare provider. To learn more about the side effects you may experience, visit Potential Side Effects.

What if there is medicine left in the delivery device after 28 days?

Do not use it. The medicine in each FORTEO Delivery Device should only be used for 28 days. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it.

FORTEO Delivery Device

I left my FORTEO Delivery Device out of the refrigerator by accident. Is it still safe to use my FORTEO Delivery Device?

If for some reason your delivery device is exposed to temperatures above the recommended 36°F to 46°F (2°C to 8°C) longer than the few minutes it takes to complete giving yourself your injection, do not throw the delivery device away. Put it back in the refrigerator and call The Lilly Answers Center (TLAC) at 1-800-LillyRx (1-800-545-5979) and they will be able to help you determine if your delivery device is still safe to use.

What is the FORTEO Storage Case?

Tabs to track the total number of delivery devices you'll use during your entire course of treatment (up to a maximum of 24 months over your lifetime) with FORTEO—so you know where you stand in your treatment progress

Sunday through Saturday slots to organize needles for the upcoming week (the same way a weekly pillbox works)

Traveling With FORTEO

How do I pass through airport security while traveling with my FORTEO Delivery Device?

Read Traveling With FORTEO on this website. Due to increasing and constantly changing security concerns, you should also consult the Transportation Security Administration (TSA). For the latest guidance in traveling with medicine and needles, visit the TSA website, call the TSA Contact Center toll-free at 1-866-289-9673 or email the TSA at TSA-ContactCenter@dhs.gov.

Indications for FORTEO:

FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.

FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones or fractures.

FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.

FORTEO is a prescription medicine given as a 20-microgram once-daily dose available in a 2.4-mL delivery device for subcutaneous injection over 28 days.

Important Safety Information About FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

Possible bone cancer. During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has rarely been reported in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.

Who should not take FORTEO?

You should not take FORTEO for more than 2 years over your lifetime.

Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

What should I tell my healthcare provider before taking FORTEO?

Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.

You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.

Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO. You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional safety information about FORTEO

There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.org.

The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

How should I store FORTEO?

Keep your FORTEO Delivery Device in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).